BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FLEX ASPHERIC

    MDR report key: 4440013 · Received January 21, 2015

    Report

    Report Number
    3003563511-2015-00005
    Event Type
    Injury
    Date Received
    January 21, 2015
    Report Date
    January 12, 2015
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RAYNER HAS CONTACTED THE FIRST AUTHOR OF THE PAPER IN ORDER TO OBTAIN FURTHER INFORMATION ON THE REPORT OF IOL OPACIFICATION INVOLVING A T-FLEX ASPHERIC 623T IOL. THE FIRST AUTHOR HAS NOW LEFT THE HEALTHCARE FACILITY WHERE THE EVENT OCCURRED AND IS AWAITING CONSENT FROM THE HOSPITAL TO RELEASE ADDITIONAL INFORMATION. THE PAPER STATES THAT THE PT HAS FUCHS ENDOTHELIAL DYSTROPHY. THE RAYNER IFU CONTRAINDICATES CORNEAL DECOMPENSATION AND ENDOTHELIAL INSUFFICIENCY.

    Description of Event or Problem · 1

    RAYNER INTRAOCULAR LENSES LIMITED IDENTIFIED A CASE OF IOL OPACIFICATION INVOLVING A RAYNER T-FLEX ASPHERIC 623T IOL IN A PAPER TITLED 'INTRAOCULAR LENS OPACIFICATION AFTER CORNEAL ENDOTHELIAL KERATOPLASTY: ELECTRON MICROSCOPE AND X-RAY ELEMENT SPECTROSCOPY ANALYSIS'. "AN (B)(6) MAN PRESENTED WITH BLURRED VISION IN THE RIGHT EYE CAUSED BY CATARACT THE FUSCH ENDOTHELIAL DYSTROPHY THE RIGHT-EYE CDVA WAS 6/60. PHACO-EMULSIFICATION AND IOL IMPLANTATION (623T, RAYNER INTRAOCULAR LENSES LTD.) WERE PERFORMED. THE IOL WAS HYDROPHILIC ACRYLIC AND WAS MANUFACTURED FORM RAYACRYL A PROPRIETARY COPOLYMER OF 2-HEMA AND PMMA WITH ETHYLENE GLYCOL DIMETHACRYLATE AS A CROSS-LINKING AGENT. THE CDVA IMPROVED BUT WITHIN 16 MONTHS POST SURGERY DECREASED TO 6/60 AGAIN BECAUSE OF ENDOTHELIAL FAILURE. DESCEMET-STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY WAS PERFORMED IN THE RIGHT EYE USING THE METHOD IN CASE 1. WITHIN 1 MONTH, THE CDCA IMPROVED TO 6/6. AFTER ANOTHER MONTH, HOWEVER, ANTERIOR SURFACE OPACIFICATION WAS NOTED AND CDVA WAS 6/9. AT LAST FOLLOW-UP 2 YEARS LATER, THE OPACIFICATION HAD REMAINS STABLE AND ASYMPTOMATIC AND THE CDVA REMAINED 6/9".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48990 T-FLEX ASPHERIC HQL - INTRAOCULAR LENS HQL RAYNER INTRAOCULAR LENSES LIMITED 623T NOT AVAIALBLE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR DSAEK - DATE OF SURGERY UNK